Recalled Supplements Linger on U.S. Store Shelves, Study Finds
Researchers say many products with banned substances for sale six months later
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Two-thirds of dietary supplements recalled by the U.S. Food and Drug Administration (FDA) because they contained banned ingredients remained on store shelves at least six months after they were recalled, a new study finds.
For example, in July 2013, researchers were able to purchase EverSlim -- a weight-loss supplement that had been recalled in February 2012 by the FDA. The product was recalled for containing sibutramine, a substance that's banned in the United States, the study reported.
What's more, the product purchased in July 2013 still contained sibutramine. It also was found to contain fluoxetine, a prescription antidepressant, according to the researchers. The expiration date on the bottle was Jan. 2018, the researchers reported.
"What we found was alarming," said lead researcher Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School in Boston.
These supplements contained not only the same prescription drugs the FDA cited in the recall, but also other substances, such as banned drugs and drugs not tested on humans, he said.
"The system for getting these drugs off the market is clearly not working," Cohen said. "The FDA has a lackluster approach," he said.
For the study, Cohen and colleagues analyzed 27 of 274 supplements recalled by the FDA. The mean time of purchase was 34 months after recall, according to the study. That means half were purchased before 34 months and the other half after that time.
Banned substances identified in recalled supplements included the weight-loss drug sibutramine and drugs similar to sibutramine, the erectile dysfunction drug sildenafil (Viagra), the antidepressant fluoxetine (Prozac), the laxative phenolphthalein, breast cancer drugs called aromatase inhibitors used to boost testosterone and a number of anabolic steroids.
Of these supplements, 74 percent were made by U.S. manufacturers, he said.
The researchers found one or more banned drugs in nearly 67 percent of the supplements they bought.
Specifically, banned drugs remained in 85 percent of supplements used to enhance sports performance, in 67 percent of supplements used for weight loss and in 20 percent of supplements used for sexual enhancement, according to the study.
Moreover, 63 percent of the supplements contained the drug the FDA had cited in its recall, the researchers reported.
In addition, six supplements contained one or more banned ingredients not identified by the FDA, and some contained both the previously identified ingredient plus new drugs, the researchers found.
"I recommend avoiding all supplements that are sold as if they will help you lose weight, improve your workout or improve your sex life, because we just don't know which of those contain these dangerous drugs and which ones are benign," Cohen said.
The labels on these products list only herbal contents and not the drugs they may contain, Cohen noted. Consumers have no way of knowing what they are buying, he said.
"Stay away from these combination products that claim to have some beneficial effect," Cohen suggested.
The report was published in the Oct. 22/29 issue of the Journal of the American Medical Association.
FDA's ability to regulate supplements is limited, said agency spokeswoman Jennifer Dooren. Manufacturers and distributors do not need FDA approval to sell dietary supplements.
"The agency faces the challenge of providing effective deterrents to prevent unscrupulous firms from fraudulently marketing and importing these products," she said.
"Even after recall and enforcement action against one major distributor, the product may continue to be widely sold," Dooren said.
The FDA recognizes that enforcement is not the only means of preventing consumer exposure to these dangerous products, Dooren said. "The FDA has issued hundreds of consumer alerts and press announcements warning consumers about tainted products," she said.
Scott Melville, CEO of the Consumer Healthcare Products Association, another industry group, said, "Unapproved or adulterated drugs masquerading as lawful supplements is a threat to public health and to consumer confidence in the supplement industry."
Melville said his group supports FDA's oversight. "This is the best way to ensure manufacturers are adhering to good manufacturing practices and to stop rogue supplement makers from spiking their products and putting the health of the public at risk," he said.
For more about supplements, visit the U.S. Food and Drug Administration (http://www.fda.gov/Food/DietarySupplements/ ).
SOURCES: Pieter Cohen, M.D., assistant professor of medicine, Harvard Medical School, Boston; Scott Melville, CEO, Consumer Healthcare Products Association, Washington, D.C.; Jennifer Dooren, spokeswoman, U.S. Food and Drug Administration; Oct. 22/29, 2014, Journal of the American Medical Association
All U.S. Residents Returning From Ebola-Stricken Countries to Be Tracked, CDC Says
Travelers will have to take own temperatures, report to local health departments for 21-day incubation period
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Public health officials plan to actively monitor all U.S. residents returning home from one of the three Ebola-affected nations in West Africa, the Centers for Disease Control and Prevention announced Wednesday.
The new monitoring program, which starts Monday, will require anyone back from Liberia, Guinea or Sierra Leone to check their temperature twice a day and report back daily to their local public health department, CDC Director Dr. Tom Frieden said in a Wednesday press conference.
"State and local authorities will require travelers to report their temperature, and the presence or absence of Ebola symptoms aside from a fever," he said. "They also will be required to coordinate with local public health officials if they intend to travel, and make arrangements to have their temperature monitored during travel."
Similar measures already have been implemented to track any residents of the three West African nations who travel to the United States.
Experts say 21 days is the longest it can take for Ebola to develop in a person.
The new program is intended to make sure that a person with Ebola is isolated early in the course of their illness, Frieden explained.
"That will reduce the chance that Ebola will spread to close contacts and health care workers," he said.
The monitoring program will concentrate on six states where 70 percent of U.S. travelers to the West African countries reside -- New York, Pennsylvania, Maryland, Virginia, New Jersey and Georgia. The CDC will reach out to public health officials in other states as necessary.
Most of the travelers are expected to be either journalists or people who have gone to the region to help fight the Ebola epidemic, Frieden noted.
Returning travelers will be required to provide detailed contact information, including e-mail addresses, home addresses, and contact information for a friend or relative, he said.
The travelers also will be handed a care kit that includes a thermometer, a tracking log, a pictorial description of symptoms, a colored card they can present to health care providers if they are ill, and information on where to call and what to say if they develop symptoms, Frieden said.
Above all, the entry contact is intended to "convey the fundamental message that if you become sick, get care quickly because that could save your life and protect your family," he said.
Regarding ongoing Ebola monitoring efforts in the United States, Frieden said:
Four West African travelers who have been taken to the hospital as a result of entry screening are not believed to have Ebola, although one remains under observation. The four are among 562 people from the three countries who have gone through entry screening at U.S. airports; all others were cleared for entry.
About 50 health care workers in Dallas who cared for the first diagnosed U.S. patient with Ebola, Thomas Eric Duncan, are two-thirds of the way through their 21-day monitoring program. The first two weeks represent 90 percent of the risk of contracting Ebola. They are being monitored because two of Duncan's nurses contracted Ebola during his care.
In other Ebola news:
Newly appointed "Ebola czar" Ron Klain started his new assignment Wednesday, meeting with President Barack Obama and various White House teams leading the government's response to Ebola.
Pharmaceutical giant Johnson & Johnson announced Wednesday that it is committing $200 million to the testing of an Ebola vaccine. The company plans to begin safety trials in January and hopes to produce 1 million doses in 2015, with 250,000 available for clinical trials by May, The New York Times reported.
Visit the U.S. Centers for Disease Control and Prevention (http://www.cdc.gov/vhf/ebola/ ) for more on Ebola.
SOURCES: Oct. 22, 2014, news conference with: Tom Frieden, M.D., U.S. Centers for Disease Control and Prevention, New York Times
U.S. Cameraman Treated for Ebola 'Free' of the Virus
After two weeks of treatment at Nebraska Medical Center, hospital says Ashoka Mukpo can go home to Rhode Island
TUESDAY, Oct. 21, 2014 (HealthDay News) -- The freelance cameraman who was diagnosed with Ebola while working for NBC News in Liberia has cleared the virus from his system and can leave the special isolation unit at Nebraska Medical Center in Omaha, where he had been treated for the past two weeks, the hospital said Tuesday.
A blood test confirmed by the U.S. Centers for Disease Control and Prevention found that Ashoka Mukpo, 33, can head home to Providence, R.I., NBC News reported Tuesday night.
"Recovering from Ebola is a truly humbling feeling," the hospital quoted Mukpo as saying. "Too many are not as fortunate and lucky as I've been. I'm very happy to be alive."
And in a statement released Wednesday morning, Mukpo expressed gratitude to an American medical missionary who battled and beat Ebola: "Thank you to Dr. Kent Brantly, whose generous blood donation played a pivotal role in my recovery. May his health flourish and his compassion be known to all," Mukpo's statement read.
Mukpo is one of eight Americans who have been diagnosed with the often deadly virus that has been plaguing three West Africa nations -- Guinea, Liberia and Sierra Leone -- since the spring.
Another patient, Nina Pham, is being treated at the U.S. National Institutes of Health Clinical Center in Bethesda, Md.; her condition was upgraded from fair to good on Tuesday.
Pham was one of two American nurses at a Dallas hospital who contracted Ebola while caring for Thomas Eric Duncan, a Liberian national who was the first Ebola patient to be diagnosed on American soil. The other nurse, Amber Vinson, is being treated at Emory University Hospital in Atlanta.
The latest good news followed reports that an unidentified patient being treated at Emory is now "free of Ebola virus disease" and was discharged Sunday from the facility, the medical center said in a statement released Monday afternoon.
The man, who has requested anonymity since being admitted to Emory's Serious Communicable Disease Unit on Sept. 9, now poses no threat to public health and has left the hospital for an "undisclosed location," the hospital added.
Emory had previously successfully treated two medical missionaries who became infected in West Africa, the site of the worst Ebola outbreak in history.
Also on Monday, health officials said dozens of people who had contact with Duncan, who died on Oct. 8, are no longer in danger of catching the disease.
Those people included the fiancee and other family members of Duncan, who contracted the disease in his home country before arriving in Dallas last month.
Also cleared were the paramedics who drove Duncan to Texas Health Presbyterian Hospital in Dallas on Sept. 28 and health care workers who drew or processed his blood. And a mandatory quarantine was lifted for a homeless man who later rode in the same ambulance as Duncan before it was disinfected.
All told, the 21-day monitoring period ended Sunday and Monday for roughly 50 people.
An estimated 120 people remain under watch because they could have had contact with one of the three people in Dallas who came down with the disease.
Federal health officials have said that symptoms of Ebola show up within 21 days of exposure to the virus.
In other developments:
Nigeria, Africa's most populous country with 160 million people, has been declared free of Ebola. Officials attributed aggressive health care measures that led to just 20 cases of infection and eight deaths.
Leaders of the European Union have set a goal of nearly $1.3 billion in aid to help combat the Ebola outbreak in West Africa.
Meanwhile, U.S. health officials on Monday tightened guidelines for health care workers treating Ebola patients.
The new recommendations call for full-body suits and hoods with no skin exposure and use of a respirator at all times. There will also be stricter rules for removing equipment and disinfecting hands, and the designation of a "site manager" to supervise the putting on and taking off of equipment used while treating a patient.
The revised guidelines are apparently in response to the two nurses in Dallas who became infected with Ebola while treating Duncan.
Health officials aren't sure how the nurses became infected with Ebola.
But, Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said Sunday that the nurses caring for Duncan had some of their skin exposed.
The Ebola outbreak in West Africa has killed nearly 4,900 people out of nearly 10,000 reported cases, according to the World Health Organization.
For more on Ebola, visit the World Health Organization (http://www.who.int/csr/disease/ebola/en/ ).
SOURCES: Oct. 20, 2014, statement, Emory Health Sciences; Oct. 18, 2014, White House weekly address; NBC News;
Where Ebola Battles Are Won
Four special U.S. medical centers are first-line treatment choices, but many local hospitals up to the challenge, experts say
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Four hospitals that are home to advanced biocontainment facilities have become America's ground zero in the treatment of Ebola patients.
Their special isolation units feature layer upon layer of safety measures to prevent the spread of nightmare pathogens, not just Ebola. They include special air filters, dunk tanks full of antiseptic, dedicated lab equipment and so-called autoclaves to sterilize any medical waste before it is transported from the unit.
But they also feature limited bed space -- just enough to treat 11 patients, nationwide.
As a result, many community hospitals across the country are now studying these units and figuring out which infection-control protocols can be quickly adopted if a patient is diagnosed with Ebola.
The most important features of these units can be embraced by local hospitals if need be, said Dr. Craig Smith, medical director of infectious diseases at University Health Care System in Augusta, Ga., and a spokesman for the Infectious Diseases Society of America.
"The idea of isolation itself is well-trained and well-ingrained in all of us," Smith said, noting that hospital workers routinely deal with virulent diseases like meningitis, tuberculosis and MRSA. "Every hospital can come up with a contingency plan to handle a highly contagious disease. We take care of scary diseases every day, all the time. The problem is the logistics. It takes money, it takes equipment, it takes people being trained and practice."
The four U.S. hospitals with biocontainment units are Emory University Hospital in Atlanta, the U.S. National Institutes of Health Clinical Center in Bethesda, Md., Nebraska Medical Center in Omaha and St. Patrick Hospital in Missoula, Mont.
The two Dallas nurses who contracted Ebola from the first patient diagnosed in the United States have each been sent to one of these hospitals. Nina Pham, 26, took one of the two beds available at the NIH Clinical Center, while Amber Vinson, 29, occupies one of three beds at the Emory isolation unit.
These hospitals have already successfully treated a handful of people who contracted the deadly virus while serving as aid workers in West Africa, site of the worst Ebola epidemic in history.
The special isolation units are all located near laboratories where researchers study some of the world's most dangerous viruses and bacteria, Smith said.
"These units weren't designed to be part of an Ebola response. They were designed to support research, primarily, and then if something ever happened we would have them available," he said. "They have been functional and practicing. They have had patients you've never heard about."
The units' protective features start with their location in the hospital, explained Dr. Mark Rupp, director of infection control at the Nebraska Medical Center.
"It's removed from the usual places we care for patients," he said. "It's someplace that's physically removed and secure, and no one comes down that hallway who isn't authorized."
The units have negative air pressure, meaning that air always flows into the patient room from outside rooms -- a feature intended to prevent the spread of airborne germs. The air also is scrubbed by filters before being expelled through the exhaust system.
Objects leaving the patient rooms are sterilized by being placed into "dunk tanks" full of a germ-killing agent. "If we do have to take something out of the unit, it goes through a tank full of disinfectant and is pulled out of the other end," Rupp said.
The units also feature an autoclave that uses steam to sterilize all medical waste before it's disposed, and a special anteroom in which health care workers can safely don and remove protective suits.
"It's not the facility that's the most important part," Rupp said. "It's the team and the training that has gone into preparing these folks."
For example, Nebraska Medical Center has a very specific set of safety equipment that workers wear when entering a patient's room. But there's also a person called the "Donner" whose only job is to help workers put the gear on correctly, Rupp said. A "Doffer" waits outside and does nothing but help people take off gear without contaminating themselves.
The new guidelines for the safe care of Ebola patients issued by the federal Centers for Disease Control and Prevention on Monday reflect this emphasis on personnel. They ask hospitals to rigorously train workers on taking on and off the safety gear, and to appoint a trained monitor who does nothing but help workers put on and remove their gear.
Many of these units' technological features can also be adapted for Ebola by local hospitals, Rupp said.
Since Ebola isn't airborne, special ventilation systems aren't necessary. A bucket with a bleach solution can double for the antiseptic dunk tank. Hospitals can purchase or borrow an autoclave big enough to handle medical waste, or store the waste in a separate area until pickup arrangements are made, he said.
Hospitals do need to set aside a remote and secure area for their isolation units, and that area needs to be large. In treating its first Ebola patient, survivor and medical missionary Dr. Rick Sacra, Nebraska Medical Center learned that "it takes a lot more physical space than we first thought," Rupp said.
Advanced medical equipment sent into the isolation area should remain there, because it's too much to ask that the devices be thoroughly sterilized after every use. Nebraska soon found its isolation room cluttered with a portable X-ray, an EKG, an ultrasound, a dialysis unit and other equipment, Rupp said.
Workers also need plenty of room to take off their gear safely, and to separate clean protective equipment from contaminated pieces.
"It takes a lot of space for all the equipment and all the waste that's generated," he said.
But mainly, running such an isolation unit requires common sense and planning. Take the issue of human waste, which at the height of infection is swarming with Ebola virus.
"We put it into the toilet bowl, and then we treat that waste with a disinfectant," Rupp said. Workers pour antiseptic into the toilet and let it sit long enough to kill off the virus, before flushing the waste into the sanitary sewer system, he said.
For more on Ebola, visit the U.S. Centers for Disease Control and Prevention (http://www.cdc.gov/vhf/ebola/ ).
SOURCES: Craig Smith, M.D., medical director, infectious diseases, University Health Care System, Augusta, Ga.; Mark Rupp, M.D., director, infection control, Nebraska Medical Center, Omaha
Many Americans in Debt, Bankruptcy Paying for Cancer Care
Others cut back on food, medicines trying to cover costs, studies found
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Besides the danger and worry from the disease itself, many Americans battling cancer are faced with high bills for medical care, two new reports show.
One-third of cancer survivors in the United States say they have experienced money or work problems due to cancer care, while even many cancer patients who have insurance say they have had to change their lifestyle and medical care due to the financial burden of treatment, the research shows.
The findings were presented Tuesday in Boston at a meeting of the American Society of Clinical Oncology (ASCO).
"We found that many cancer survivors, particularly those who are younger or from underserved populations, experience financial or work-related hardship -- even when insured and years out from treatment," Robin Whitney, lead author of one of the studies, said in an ASCO news release. Whitney is a cancer survivor and a graduate student at the University of California, Davis, School of Nursing.
In the study, Whitney's team surveyed nearly 1,600 U.S. cancer survivors. They found that 27 percent reported at least one financial hardship -- such as debt or bankruptcy. Thirty-seven percent said that they had to make changes at work such as having to take extended time off or delaying retirement, because of the demands of cancer care.
These types of problems were most common among women, younger patients, racial/ethnic minority patients, and those without insurance, the study found.
"Addressing these challenges is an important aspect of providing quality cancer care, because they can substantially impact quality of life and health outcomes," Whitney added.
Among the cancer survivors in the study, 14 percent were in active treatment, 46 percent were less than five years post-treatment, and 39 percent were five or more years post-treatment. Those in active treatment reported more than double the amount of financial hardship than those who were less than five years post-treatment.
Financial problems were more than twice as high among survivors younger than 65 than among older survivors, 67 percent higher among those without insurance than among those with insurance, and 42 percent higher among non-whites than whites, the study authors said.
Work changes were much more common among women than men, more than twice as common among those in active treatment than those who were less than five years post-treatment, and 57 percent more common among non-whites than whites, the study found.
Another study presented at the same meeting included 174 people undergoing treatment for breast, colon, or other solid tumor cancers. All of them were insured and had asked for assistance through a national co-payment assistance program.
Among the patients, 89 percent had had to make at least one lifestyle change to accommodate cancer care, the researchers said. Lifestyle changes included spending less on leisure activities (78 percent), spending less on basics like food and clothing (57 percent), borrowing money (54 percent), and spending savings (50 percent).
Those most likely to make lifestyle changes included patients who were younger, had higher levels of education and had spent less time receiving chemotherapy. Younger and lower-income patients were more likely to make changes in their medical care than older and higher-income patients.
Perhaps even more troubling were cutbacks some patients felt they needed to make when it came to their medical care, the study authors noted. Thirty-nine percent said they made at least one change in their medical care, which included steps such as not filling prescriptions (28 percent) and taking less medication than prescribed (23 percent).
All of this means that "we need a better, more open dialog between patients and providers about the financial burden associated with cancer care costs," study lead author Dr. Ryan Nipp, an oncology fellow at Dana-Farber Cancer Institute, said in the ASCO news release.
The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.
The U.S. National Library of Medicine has more about living with cancer (http://www.nlm.nih.gov/medlineplus/cancerlivingwithcancer.html ).
SOURCE: American Society of Clinical Oncology, news releases, Oct. 22, 2014
Experimental Infertility Treatment Seems Effective, Cheaper
Fertilization occurs in the vagina, instead of petri dish, researchers say
TUESDAY, Oct. 21, 2014 (HealthDay News) -- A crucial part of conventional in vitro fertilization (IVF) -- the incubation of embryos in a laboratory dish -- can instead take place in a device inside the vagina, new research suggests.
Scientists from the United States and Colombia contend that the device, called an INVOcell, might sharply cut costs for pricey IVF procedures among certain women. It could also make the technology more accessible to those who don't live near big-city assisted reproduction centers, the researchers said.
In a small U.S. study, pregnancy rates were nearly identical between women whose eggs were conventionally incubated with sperm in the lab for five days and those whose eggs and sperm were placed in the INVOcell device for the same amount of time.
Once thought of as producing "test tube babies," IVF is one of the most prominent forms of assisted reproduction and has been used in the United States since 1981. About 65,000 babies were born in the United States in 2012 through 176,000 assisted reproduction cycles, typically costing upwards of $10,000 apiece, according to the U.S. Centers for Disease Control and Prevention.
"One reason assisted reproduction is limited is because of cost, and part of that is the incubation systems we use ... which are complex devices that require calibration and daily quality control checks," said study author Dr. Kevin Doody, founder of the Center for Assisted Reproduction in Bedford, Texas.
"We think we've been able to simplify the IVF process to require minimal monitoring with a high pregnancy rate," Doody added.
The research is scheduled for presentation Wednesday at the American Society for Reproductive Medicine meeting in Honolulu. Studies presented at scientific conferences typically have not been peer-reviewed or published, and results are considered preliminary.
Optimal candidates for the INVOcell technique are infertile women able to produce many viable eggs using ovulation-stimulating hormones, experts said.
Manufactured by INVO Bioscience of Medford, Mass., the small, cylindrical device can be held in place in the vagina with a diaphragm, where the vaginal environment is expected to maintain the right temperature, pH and other conditions necessary for fertilization and early embryo development. After three to five days, the device is removed and embryos can be recovered and transferred to the uterus.
Doody's study divided 33 infertile women between ages 18 and 38 into two groups. After egg retrieval, each patient's eggs were incubated in a petri dish with sperm for two to four hours, after which up to 10 eggs per patient were either placed in the INVOcell device or moved to the next stage of conventional lab incubation.
Embryos resulting from both methods were of comparable quality, and similar pregnancy rates resulted: 10 of 17 women from the INVOcell group and 10 of 16 from the incubator culture group reported ongoing pregnancies.
"My impression is wow, this is really interesting stuff," said Dr. Timothy Hickman, chief of reproductive endocrinology at Houston Methodist Hospital in Texas. "IVF tends to be a highly complex process ... and here's a novel way to try to provide something for a certain population that can benefit. This is never going to replace an IVF lab, but maybe for a certain population it may work out right."
A second study on the INVOcell device presented at the reproductive medicine meeting indicated that the technique is also effective when eggs need to be manually injected with sperm to achieve fertilization, a procedure called intracytoplasmic sperm injection.
Dr. Elkin Lucena, scientific director and founder of Colombian Fertility and Sterility Center in Bogota, led research on couples who underwent 172 cycles of IVF in which their embryos were incubated in the INVOcell device for three days, with an average of two embryos transferred into the uterus afterward. Pregnancy resulted in 40 percent of embryo transfers -- roughly the same rate as conventional IVF.
"Especially from a psychological impact, couples feel they're participating in conception too and carrying their own [offspring] inside of them instead of in a lab," Lucena said. "And the cost is lowered a lot, which is making it easier for people to access these techniques."
The INVOcell vaginal device, currently under review by the U.S. Food and Drug Administration, is already approved for use in Canada and several other countries.
Doody, who said he owns about $10,000 of publicly traded stock in INVO Bioscience, said he thinks using the device could halve the cost of a typical cycle of IVF treatment.
"My guess is that at least two-thirds of IVF patients could be treated with this type of [technique]," Doody said.
One difference between the conventional treatment and the INVOcell approach is that eggs and sperm are placed together in the intravaginal device before knowing if fertilization has occurred.
"That is a waiting game for the patient," said Doody. "But in all the cycles we've done, we've not had any cases where we didn't have embryos [created] to transfer back to the uterus," he added.
The U.S. National Library of Medicine has more about IVF (http://www.nlm.nih.gov/medlineplus/ency/article/007279.htm ).
SOURCES: Kevin Doody, M.D., founder, Center for Assisted Reproduction, Bedford, Texas; Elkin Lucena, M.D., scientific director and founder, Colombian Fertility and Sterility Center, Bogota, Colombia; Timothy Hickman, M.D., chief, reproductive endocrinology, Houston Methodist Hospital, and medical director, Houston IVF, Houston; abstracts scheduled for presentation Oct. 22, 2014, American Society for Reproductive Medicine annual meeting, Honolulu, Hawaii
Controversial Chemical May Leach Into Skin From Cash Receipts
Skin care products may also boost absorption of BPA, study finds
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Touching cash register receipts can dramatically increase your body's absorption of a potentially dangerous chemical, bisphenol A (BPA), researchers report.
BPA, originally created as an estrogen supplement, has been linked to developmental problems in infants and children, and cancer, obesity, diabetes and heart disease in adults, researchers say.
The chemical is found in products ranging from plastic water bottles and food-can linings. It is also used as a print developer in thermal paper for airline tickets and store and ATM receipts, according to the researchers.
"Thermal paper is typically used for cash register receipts in restaurants, making BPA contamination of food from fingers and hands likely," said lead author Julia Taylor, an assistant professor in the division of biological sciences at the University of Missouri.
Because BPA is an endocrine disruptor, the health risks to humans are considerable, she contends.
"BPA from thermal paper can be absorbed into your blood rapidly. At the levels measured in this study, many diseases such as diabetes and disorders such as obesity may increase," Taylor said.
A similar chemical used to replace BPA in thermal paper also "can pose a threat to human health," she added. "Handling [thermal paper receipts] should be kept to a minimum."
Moreover, commonly used skin care products appear to boost the absorption rate of BPA, Taylor said.
For the study, published Oct. 22 in the online journal PLOS One, Taylor's team had people touch cash register receipts after using a hand sanitizer. The researchers then took blood and urine samples.
They found that BPA from these receipts seeped into participants' skin, dramatically increasing the amount of BPA in their body. Hand sanitizer boosted the rate of absorption, the researchers said.
To mimic behavior at fast-food restaurants, some participants were given French fries to eat with their hands after handling BPA-coated receipts. Here, too, the researchers found that BPA was rapidly absorbed through the skin.
Taylor said that because BPA is so widely used, it can be detected in the urine of over 90 percent of Americans.
BPA is being replaced in some cases by the chemical bisphenol S (BPS), Taylor said.
"The shift toward manufacturers' use of BPS in thermal paper may be a response to public awareness about BPA and a desire for a more acceptable substitute," Taylor said.
However, it may be no safer, she said. BPS is similar to BPA in that it also mimics estrogen, Taylor said.
"It is also more persistent in the environment. Because of these two factors alone, as a substitute it is not an improvement over BPA," she said. "More broadly, the recycling of paper often incorporates paper receipts, and both of these compounds end up in recycled paper products, further increasing the potential for exposure."
Steven Gilbert, director and founder of the U.S. Institute of Neurotoxicology and Neurological Disorders in Seattle, said 15 billion pounds of BPA are used each year in the United States, and they're "going someplace."
"All of us have BPA in our bodies. This is an interesting example of a source of BPA exposure," Gilbert said.
"We should be more careful with the chemicals we put into the environment," he added.
Steven Hentges, a spokesman for the American Chemistry Council, an industry group, took issue with the study, calling the experiment "unrealistic."
Moreover, he stressed that BPA is safe.
"Data from the U.S. Centers for Disease Control and Prevention demonstrate that consumer exposure to BPA -- from all sources -- is extremely low," he said. "Typical BPA exposure from all sources is about 1,000 times below safe intake levels set by government bodies in the U.S., Canada and Europe."
In addition, the U.S. Food and Drug Administration has said BPA is safe for use in food containers, Hentges said. "FDA's current perspective is based on its review of hundreds of studies, as well as its comprehensive research on BPA," he said.
For more on BPA, visit the U.S. National Institutes of Health (https://www.niehs.nih.gov/health/topics/agents/sya-bpa/ ).
SOURCES: Julia Taylor, Ph.D., assistant professor, division of biological sciences, University of Missouri, Columbia; Steven Gilbert, Ph.D., director and founder, U.S. Institute of Neurotoxicology and Neurological Disorders, Seattle; Steven Hentges, Ph.D., spokesman, American Chemistry Council; Oct. 22, 2014, PLOS One, online
Depression After Heart Attack May Be More Common for Women
Researcher believes issue has been 'largely unnoticed'
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Women are at greater risk for anxiety and depression after a heart attack than men, a new study finds.
Researchers looked at 160 patients in Lithuania who were interviewed at least one month after suffering a heart attack. About one-quarter of the patients were depressed and 28 percent of those had been treated with antidepressants.
Women were more likely than men to have depression and anxiety, and the conditions were more severe in women, according to the findings presented Sunday in Geneva at the annual meeting of the Acute Cardiovascular Care Association of the European Society of Cardiology.
Further research is needed to determine why women are more likely than men to develop anxiety and depression after a heart attack, study author Dr. Pranas Serpytis of Vilnius University in Lithuania said in an association news release.
The study showed smokers were more likely to have anxiety after a heart attack than former smokers and those who never smoked. But there was no link between smoking and increased risk of depression after a heart attack, the researchers said.
The study authors also found that physical inactivity was associated with an increased risk of depression after a heart attack.
"The World Health Organization predicts that by 2020 depression will be the second leading cause of disability and mortality in the world, surpassed only by ischemic heart disease. Major depression follows [heart attack] in approximately 18 percent of cases and is an important predictor of disability and poor quality of life in the year [after a heart attack]," Serpytis said.
Patients with depression are nearly six times more likely to die within six months after a heart attack than those without depression, he added. And the increased risk of death in patients with depression persists up to 18 months after the heart attack, he said. Nevertheless, "the condition remains under-recognized and undertreated," he noted.
Serpytis said women are misrepresented in many clinical studies on heart attack even though they often have worse outcomes.
"Our study shows that women are more likely to develop anxiety and depression after [heart attack] than men but until now this issue has been largely unnoticed," he said. Doctors should assess heart attack patients, particularly women, for anxiety and depression so that timely treatment can be started, he added.
"Our study suggests that encouraging patients to quit smoking and increase their physical activity levels should reduce their risks of anxiety and depression after [heart attack]," he said.
More research is needed on the links between heart attack and mental health problems, Serpytis concluded. Links found in the study did not prove a cause-and-effect relationship.
Research presented at meetings is usually considered preliminary until published in a peer-reviewed medical journal.
The American Academy of Family Physicians offers tips for heart attack survivors (http://familydoctor.org/familydoctor/en/diseases-conditions/heart-attack/treatment/tips-for-recovering-and-staying-well.printerview.all.html ).
SOURCE: Acute Cardiovascular Care Association, news release, Oct. 19, 2014
Discussing Ebola: Children Feel Safe, Calm When Adults Do, Too
Be prepared with appropriate answers for the inevitable questions, experts say
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- With so much news focused on the Ebola epidemic in Africa, parents and other caregivers should think about how to help children feel safe, experts say.
"Children are almost always listening," said Dr. Allison Baker, a pediatric psychopharmacologist at the Child Mind Institute in New York City. "They hear words and phrases, but this doesn't mean that they have the ability to contextualize it the way we as adults do."
She said it's important not to underestimate how much children are listening or to overestimate how much they can understand what they hear.
"Even if they parrot a phrase or word back at you -- 'I'm scared about Ebola' -- this doesn't mean they have a comprehensive understanding of what they are saying," Baker said. "It may just be something they heard at school. I would caution parents against reading too deeply into things their children are saying."
At the same time, however, parents need to be aware that children feeling genuinely fearful can't work through frightening information the way adults do, said Sarah Feuerbacher, director of the Center for Family Counseling at Southern Methodist University in Plano, Texas.
"What we need to keep in mind for children is that they don't have the mental or emotional capacity to process through scary information to appropriately define a stressor," she said.
Kids look to caretakers to protect them and to be a filter for possible stressors, she said. This includes reducing their exposure to news about the viral outbreak linked to nearly 4,500 deaths in West Africa and one in the United States.
"Listening to continuous news coverage about crises or traumatic events is not good for adults, much less children," she said.
Kids start becoming more aware and able to understand what they hear around age 7, Baker said. But Feuerbacher said the desire to make sense of their environment starts even earlier.
"Typically around age 4, children begin developing a sense of judgment, which means they are seeking to learn and understand what is happening on a larger scale within the world around them," Feuerbacher said. That means a 4-year-old may be likely to ask questions about a newscast heard in the car.
If a child does ask about Ebola, don't make assumptions about what the child might think or feel.
"Let the children lead the conversation by asking them what they do know and what questions they have," Feuerbacher said. Even if children say they are scared of Ebola, they may think of it as a monster, for example, rather than a disease, she said, so parents should ask questions such as "What scares you about it?"
As parents answer children's questions, they should help children know what they can do to stay safe, Feuerbacher said. She offered the following possible script for parents: "Do you remember when you had the flu last year? Ebola looks a lot like the flu and doctors are learning how to help people be treated for it and keep from getting it. What keeps us healthy from all sicknesses is washing our hands all the time, not eating or drinking after anyone and keeping our hands to ourselves. Do you have any ways that you'd like to help our family stay healthy this year?"
This kind of discussion educates kids on healthy practices without being threatening, Feuerbacher said, and it provides them a sense of control over their lives by actually engaging in healthy practices.
Baker added that children are more likely to come to adults with concerns if they feel safe asking questions in the first place.
"I would advise parents to work on creating a calm and supportive environment in which children know they can ask anything that may come up at school or that they don't understand," Baker said. In general, she said, "it's best not to force children to talk about something if they're not bringing it up."
Parents don't need to bring up Ebola if they do not think their children have heard about it, both experts said.
"There is a school of thought that it is better to bring it up because then you are the one giving them information upfront," Baker said. However, "the risk of this approach is that you may be introducing something that has not even crossed their radar, and out of your own anxiety."
Children pick up on that anxiety, Baker said, so parents should model healthy responses to unsettling information.
Feuerbacher explained that if an adult acts scared or panicked, children will assume they should also. "If an adult is calm and actively using protective measures," she added, "the child will feel a sense of security and empowerment that they are safe and in control of their situation."
The U.S. Department of Homeland Security has tips for addressing children's fears ( http://www.ready.gov/kids/parents/coping ).
SOURCES: Allison Baker, M.D., pediatric psychopharmacologist, Child Mind Institute, New York City; Sarah Feuerbacher, Ph.D., director, Center for Family Counseling, Southern Methodist University, Plano, Tex.
Mutations Linked to Blood Cancers Rise With Age, Study Shows
Still, these diseases occur in less than 0.1 percent of elderly Americans, researchers say
WEDNESDAY, Oct. 22, 2014 (HealthDay News) -- Blood cell mutations linked to the blood cancers leukemia and lymphoma increase as people get older, according to a new study.
Researchers analyzed blood samples from nearly 3,000 Americans, ages 10 to 90, and found the mutations in less than 1 percent of those ages 40 to 49. By the time people are between 70 and 79, 5 percent will have blood cell mutations, according to the study. For people between 80 and 89, more than 6 percent will be affected, the researchers found.
Cell mutations accumulate as people age, and most are harmless, according to the researchers. They said that having these blood cell mutations associated with leukemia and lymphoma doesn't mean a person will develop these blood cancers. In fact, the diseases occur in less than 0.1 percent of elderly Americans, the researchers noted.
"But it's quite striking how many people over age 70 have these mutations," study senior author Li Ding, of The Genome Institute at Washington University in St. Louis, said in a university news release.
"We don't yet know whether having one of these mutations causes a higher than normal risk of developing blood cancers. More research would be required to better understand that risk," Ding added.
The study -- published in the Oct. 19 issue of Nature Medicine-- likely underestimates the percentage of people with blood cell mutations associated with the blood cancers, according to the researchers.
They also said there's no point in people getting genetic tests in an effort to predict their risk of blood cancers.
"We would not want anyone to think they should be screened for these mutations to understand their risk of leukemia or lymphoma," study co-author and professor of oncology Dr. Timothy Ley of Washington University, said in the news release.
"The ability to understand how mutations in these genes increase a person's risk of blood cancers is a long way off, and genetic testing would be of no benefit at this time," Ley explained.
The U.S. National Cancer Institute has more about leukemia (http://www.cancer.gov/cancertopics/wyntk/leukemia ).
SOURCE: Washington University, news release, Oct. 19, 2014